Boston Scientific Regulatory Affairs Fellow - Global Operations 

United States, Minnesota, Arden Hills 

314657589

Your responsibilities will include:

• Notified body working group lead on behalf of Global Regulatory Operations (GRO) including but not limited to:
• Plan and lead monthly, quarterly, and annual notified body meetings (BSI, DEKRA, TUV SUD, GMED)
• Support uTrack NB Submission Database (NB Submission Tracker) sustaining activities
• Lead quarterly uTrack review meetings to review NB Feedback metrics and trends
• Lead activities related to additions/transfers of notified bodies (including audit support)
• Lead cross-divisional process efficiency initiatives, as needed
• Influence NB decision process(s), interpretation of regulations, cost management, etc.
• Build strong and trusted business relationships with internal and external partners
• Own regulatory SOPs and WIs applicable to this role
• Lead and operate effectively as the GRO regulatory team lead on assigned projects including global regulatory strategy development and execution, notified body submissions, standards support, and advocacy initiatives.

Required qualifications:

• Minimum of a bachelor’s degree, preferably in a scientific or engineering discipline
• Minimum of 10 years of medical device, regulatory experience ideally with notified bodies.

Preferred qualifications:

• Master's degree in regulatory affairs
• Experience in regulatory affairs with a global focus
• Ability to effectively manage multiple projects
• Strong written and oral communication skills
• Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases such as PLM
  

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.